NG198 Evidence Review F1
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Azelaic Acid
Azelaic Acid (FINACEA) Topical Foam 15% National Drug Monograph August 2016 VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives The purpose of VA PBM Services drug monographs is to provide a focused drug review for making formulary decisions. Updates will be made when new clinical data warrant additional formulary discussion. Documents will be placed in the Archive section when the information is deemed to be no longer current. FDA Approval Information Description/Mechanism of Azelaic acid is a naturally occurring C9-dicarboxylic acid that is found in plants Action (such as whole grain cereals), animals and humans. Azelaic acid has antiinflammatory, antioxidative and antikeratinizing effects. In rosacea skin, azelaic acid decreases cathelicidin levels and kallikrein 5 (KLK5) activity and possibly inhibits toll-like receptor 2 (TLR2) expression.1 A 15% gel formulation has been marketed for rosacea, and 20% cream has been available for acne vulgaris. The newer foam formulation consists of an oil- in-water emulsion and was designed to have a higher lipid content than the gel for dry and sensitive skin. Indication(s) Under Review Topical treatment of inflammatory papules and pustules of mild to moderate in This Document rosacea. Dosage Form(s) Under Foam, 15% Review REMS REMS No REMS Postmarketing Requirements See Other Considerations for additional REMS information Pregnancy Rating Category B Executive Summary Efficacy There have been no head-to-head trials comparing the foam and gel formulations of azelaic acid in terms of safety, tolerability and efficacy in the treatment of papulopustular (PP) rosacea.. In two major randomized clinical trials, azelaic acid foam produced small benefits over vehicle foam in achieving Investigator’s Global Assessment (IGA) treatment success (NNTs of 9.2 and 11.5) and in reducing inflammatory lesion counts. -
Compositions Comprising Drospirenone Molecularly
(19) & (11) EP 1 748 756 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 9/00 (2006.01) A61K 9/107 (2006.01) 29.04.2009 Bulletin 2009/18 A61K 9/48 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 9/14 (2006.01) (2006.01) (2006.01) (21) Application number: 05708751.2 A61K 9/70 A61K 31/565 (22) Date of filing: 10.03.2005 (86) International application number: PCT/IB2005/000665 (87) International publication number: WO 2005/087194 (22.09.2005 Gazette 2005/38) (54) COMPOSITIONS COMPRISING DROSPIRENONE MOLECULARLY DISPERSED ZUSAMMENSETZUNGEN AUS DROSPIRENON IN MOLEKULARER DISPERSION DES COMPOSITIONS CONTENANT DROSPIRENONE A DISPERSION MOLECULAIRE (84) Designated Contracting States: (72) Inventors: AT BE BG CH CY CZ DE DK EE ES FI FR GB GR • FUNKE, Adrian HU IE IS IT LI LT LU MC NL PL PT RO SE SI SK TR D-14055 Berlin (DE) Designated Extension States: • WAGNER, Torsten AL BA HR MK YU 13127 Berlin (DE) (30) Priority: 10.03.2004 EP 04075713 (74) Representative: Wagner, Kim 10.03.2004 US 551355 P Plougmann & Vingtoft a/s Sundkrogsgade 9 (43) Date of publication of application: P.O. Box 831 07.02.2007 Bulletin 2007/06 2100 Copenhagen Ø (DK) (60) Divisional application: (56) References cited: 08011577.7 / 1 980 242 EP-A- 1 260 225 EP-A- 1 380 301 WO-A-01/52857 WO-A-20/04022065 (73) Proprietor: Bayer Schering Pharma WO-A-20/04041289 US-A- 5 569 652 Aktiengesellschaft US-A- 5 656 622 US-A- 5 789 442 13353 Berlin (DE) Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. -
(12) United States Patent (10) Patent No.: US 9,662.400 B2 Smith Et Al
USOO9662400B2 (12) United States Patent (10) Patent No.: US 9,662.400 B2 Smith et al. (45) Date of Patent: *May 30, 2017 (54) METHODS FOR PRODUCING A (2013.01); C08B 37/003 (2013.01); C08L 5/08 BODEGRADABLE CHITOSAN (2013.01); A6 IK 38/00 (2013.01); A61 L COMPOSITION AND USES THEREOF 2300/404 (2013.01) (58) Field of Classification Search (71) Applicant: University of Memphis Research CPC ...... A61K 47/36; A61K 31/00; A61K 9/7007; Foundation, Memphis, TN (US) A61K 9/0024; A61 L 15/28: A61L 27/20; A61L 27/58: A61L 31/042; C08B 37/003 (72) Inventors: James Keaton Smith, Memphis, TN USPC ................................ 514/23, 40, 777; 536/20 (US); Ashley C. Parker, Memphis, TN See application file for complete search history. (US); Jessica A. Jennings, Memphis, (56) References Cited TN (US); Benjamin T. Reves, Memphis, TN (US); Warren O. U.S. PATENT DOCUMENTS Haggard, Bartlett, TN (US) 4,895,724. A * 1/1990 Cardinal .............. A61K9/0024 424,278.1 (73) Assignee: The University of Memphis Research 5,541,233 A 7/1996 Roenigk Foundation, Memphis, TN (US) 5,958,443 A 9/1999 Viegas et al. 6,699,287 B2 3/2004 Son et al. (*) Notice: Subject to any disclaimer, the term of this 6,989,157 B2 1/2006 Gillis et al. patent is extended or adjusted under 35 7,371.403 B2 5/2008 McCarthy et al. 2003, OO15825 A1 1/2003 Sugie et al. U.S.C. 154(b) by 0 days. 2003/0206958 A1 11/2003 Cattaneo et al. -
Ultraviolet-Visible Reference Spectra C
1536 Ultraviolet-visible Reference Spectra JP XV Butropium Bromide 1 A solution in methanol (1 in 100,000) Butropium Bromide 2 A solution in methanol (1 in 5000) Calcium Folinate An aqueous solution (1 in 100,000) JP XV Ultraviolet-visible Reference Spectra 1537 Camostat Mesilate An aqueous solution (1 in 100,000) Carbamazepine The sample solution obtained in the Assay Carbazochrome Sodium Sulfonate Hydrate An aqueous solution (1 in 100,000) 1538 Ultraviolet-visible Reference Spectra JP XV Carbidopa Hydrate A solution prepared as follows: Dissolve 0.01 g in 250 mL of a solution of hydrochloric acid in methanol (9 in 1000) Carmofur A solution in a mixture of methanol and phosphoric acid-acetic acid-boric acid buffer solution, pH 2.0 (9:1) (1 in 100,000) Carteolol Hydrochloride An aqueous solution (1 in 100,000) JP XV Ultraviolet-visible Reference Spectra 1539 Carumonam Sodium An aqueous solution (3 in 100,000) Cefaclor An aqueous solution (1 in 50,000) Cefadroxil An aqueous solution (1 in 50,000) 1540 Ultraviolet-visible Reference Spectra JP XV Cefalexin An aqueous solution (3 in 100,000) Cefalotin Sodium An aqueous solution (1 in 50,000) Cefapirin Sodium An aqueous solution (3 in 200,000) JP XV Ultraviolet-visible Reference Spectra 1541 Cefatrizine Propylene Glycolate An aqueous solution (1 in 50,000) Cefazolin Sodium An aqueous solution (1 in 50,000) Cefbuperazone Sodium An aqueous solution (1 in 50,000) 1542 Ultraviolet-visible Reference Spectra JP XV Cefditoren Pivoxil A solution in methanol (1 in 50,000) Cefixime A solution in 0.1 -
United States Patent ( 10 ) Patent No.: US 10,561,6759 B2 Griffith Et Al
US010561675B2 United States Patent ( 10 ) Patent No.: US 10,561,6759 B2 Griffith et al. (45 ) Date of Patent : * Feb . 18 , 2020 (54 ) CYCLIC BORONIC ACID ESTER ( 58 ) Field of Classification Search DERIVATIVES AND THERAPEUTIC USES CPC A61K 31/69 ; A61K 31/396 ; A61K 31/40 ; THEREOF A61K 31/419677 (71 ) Applicant: Rempex Pharmaceuticals , Inc. , (Continued ) Lincolnshire , IL (US ) (56 ) References Cited (72 ) Inventors : David C. Griffith , San Marcos, CA (US ) ; Michael N. Dudley , San Diego , U.S. PATENT DOCUMENTS CA (US ) ; Olga Rodny , Mill Valley , CA 4,194,047 A 3/1980 Christensen et al . ( US ) 4,260,543 A 4/1981 Miller ( 73 ) Assignee : REMPEX PHARMACEUTICALS , ( Continued ) INC . , Lincolnshire , IL (US ) FOREIGN PATENT DOCUMENTS ( * ) Notice : Subject to any disclaimer, the term of this EP 1550657 A1 7/2005 patent is extended or adjusted under 35 JP 2003-229277 A 8/2003 U.S.C. 154 ( b ) by 1129 days. (Continued ) This patent is subject to a terminal dis claimer . OTHER PUBLICATIONS Abdel -Magid et al. , “ Reductive Amination ofAldehydes and Ketones ( 21) Appl. No .: 13 /843,579 with Sodium Triacetoxyborohydride: Studies on Direct and Indirect Reductive Amination Procedures ” , J Org Chem . ( 1996 )61 ( 11 ): 3849 ( 22 ) Filed : Mar. 15 , 2013 3862 . (65 ) Prior Publication Data (Continued ) US 2013/0331355 A1 Dec. 12 , 2013 Primary Examiner — Shengjun Wang Related U.S. Application Data (74 ) Attorney, Agent, or Firm — Wilmer Cutler Pickering (60 ) Provisional application No.61 / 656,452 , filed on Jun . Hale and Dorr LLP 6 , 2012 (57 ) ABSTRACT (51 ) Int. Ci. A61K 31/69 ( 2006.01) Method of treating or ameliorating a bacterial infection A61K 31/00 ( 2006.01 ) comprising administering a composition comprising a cyclic (Continued ) boronic acid ester compound in combination with a car ( 52 ) U.S. -
00246-2019.Supptables
1 Table S1. List of ICD-10 codes identifying comorbidities during hospitalization for COPD exacerbation COPD J41, J42, J43, J440, J441, J449 COPD exacerbation J10, J11, J13, J14, J15, J16, J18, J20, J21, J22, J46, J170, J171, J178, J440, J441, J851, J12, A481, B012, B052, B250 Bacterial pneumonia J100, J110, J12, J13, J14, J15, J16, J170, J178, J18, J851, A481 Lung cancer C34 Other malignancy C00-26, C30-33, C37-41, C43-58, C60-76 Diabetes/abnormal glucose tolerance E10-14, R703 Bone fracture/osteoporosis M80-84 Interstitial pneumonia B221, J701, J704, J841, J848, J849, J990, J991, M321, M330, M331, M332, M351 Bronchial asthma J45, J46 Bronchiectasis J40, J41, J42, J47 Pulmonary thromboembolism I26 Mycobacterium infection A150-154, A156-159, A161-162, A165, A168-169, A19, A310, A319 Mycotic infection A420, A43, B37, B380-382, B390-392, B400-402, B410, B420, B440, B441, B449, B460, J172 Cor pulmonare I27 Congestive heart failure E059, I46, I50, I099, I110 Ischemic heart disease I20-25 Tachycardia I47-49, R000, T818 Autoimmune disease M05, M06, M08, M30-35 Stroke I60-64 Liver dysfunction B89, B181, B182, B659, B661, K702, K703, K72, K74, K761, K762, K763, K766, K767 Renal failure E102, E112, E142, I120, N17-19 GERD K21 Constipation or ileus K56, K590 Prostate hypertrophy N40 Abbreviations: COPD, chronic obstructive pulmonary disease; GERD, gastro-esophageal reflux disease 2 Table S2. List of baseline characteristics, comorbidities, and treatments before and during hospitalization for COPD exacerbation Baseline characteristics Sex, fiscal -
AMR Surveillance in Pharma: a Case-Study for Data Sharingauthor by Professor Barry Cookson
AMR Open Data Initiative AMR Surveillance in Pharma: a case-study for data sharingauthor by Professor Barry Cookson External Consultant to Project eLibrary • Division of Infection and Immunity, Univ. College London ESCMID• Dept. of Microbiology, © St Thomas’ Hospital Background of “90 day Project” Addressed some recommendations of the first Wellcome funded multi-disciplinary workshop (included Pharma Academia & Public Health invitees: 27thauthor July 2017 (post the Davos Declaration): by 1) Review the landscape of existing Pharma AMR programmes, their protocols,eLibrary data standards and sets 2) Develop a "portal" (register/platform) to access currently available AMR Surveillance data ESCMID Important ©to emphasise that this is a COLLABORATION between Pharma and others Overview of Questionnaire Content • General information - including name,author years active, countries, antimicrobials, microorganisms.by • Methodology - including accreditation, methodology for; surveillance, isolate collection, organism identification, breakpointseLibrary used, • Dataset - including data storage methodology, management and how accessed. ESCMID © 13 Company Responses author 7 by 3 3 eLibrary ESCMID © Structure of register Companies can have different ways of referring to their activities: We had to choose a consistent framework. author Companies Companyby 1 Programmes Programme A Programme B eLibrary Antimicrobials 1 2 3 4 5 company’s product comparator company’s product antimicrobials Programmes canESCMID contain multiple studies (e.g. Pfizer has© single -
2021 SELECT EX FORMULARY the Following Is a List of the Most Commonly Prescribed Brand and Generic Medications
2021 SELECT EX FORMULARY The following is a list of the most commonly prescribed brand and generic medications. It represents an abbreviated version of the formulary list that is at the core of your prescription drug benefit plan. The list is not all-inclusive and does not guarantee coverage. Some preferred medications overlap with other clinical programs and may not be covered. In addition to drugs on this list, the majority of generic medications are covered under your plan and you are encouraged to ask your doctor to prescribe generic drugs whenever appropriate. Search complete formulary drug information at elixirsolutions.com. PLEASE NOTE: Preferred brand drugs may move to non-preferred status if a generic version becomes available during the year. Any medication approved to enter the market will not be covered until reviewed by Elixir. Not all drugs listed are covered by all prescription drug benefit programs. For specific questions about your coverage, please visit elixirsolutions.com. A B CILOXAN OINTMENT digoxin abacavir tablet balsalazide CIMDUO diltiazem ER (except generics for abacavir-lamivudine BAQSIMI cinacalcet CARDIZEM LA) ABILIFY MAINTENA [INJ] BASAGLAR [INJ] ciprofloxacin dimethyl fumarate DR* abiraterone* BD ULTRAFINE INSULIN SYRINGES ciprofloxacin-dexamethasone diphenoxylate-atropine acetic acid & NEEDLES citalopram dipyridamole ER-aspirin acitretin BELBUCA CITRANATAL divalproex sodium ACUVAIL BELSOMRA clarithromycin divalproex sodium ER acyclovir capsule, tablet benzonatate (except NDCs: clarithromycin ER DIVIGEL -
)&F1y3x PHARMACEUTICAL APPENDIX to THE
)&f1y3X PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE )&f1y3X PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 3 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. Product CAS No. Product CAS No. ABAMECTIN 65195-55-3 ACTODIGIN 36983-69-4 ABANOQUIL 90402-40-7 ADAFENOXATE 82168-26-1 ABCIXIMAB 143653-53-6 ADAMEXINE 54785-02-3 ABECARNIL 111841-85-1 ADAPALENE 106685-40-9 ABITESARTAN 137882-98-5 ADAPROLOL 101479-70-3 ABLUKAST 96566-25-5 ADATANSERIN 127266-56-2 ABUNIDAZOLE 91017-58-2 ADEFOVIR 106941-25-7 ACADESINE 2627-69-2 ADELMIDROL 1675-66-7 ACAMPROSATE 77337-76-9 ADEMETIONINE 17176-17-9 ACAPRAZINE 55485-20-6 ADENOSINE PHOSPHATE 61-19-8 ACARBOSE 56180-94-0 ADIBENDAN 100510-33-6 ACEBROCHOL 514-50-1 ADICILLIN 525-94-0 ACEBURIC ACID 26976-72-7 ADIMOLOL 78459-19-5 ACEBUTOLOL 37517-30-9 ADINAZOLAM 37115-32-5 ACECAINIDE 32795-44-1 ADIPHENINE 64-95-9 ACECARBROMAL 77-66-7 ADIPIODONE 606-17-7 ACECLIDINE 827-61-2 ADITEREN 56066-19-4 ACECLOFENAC 89796-99-6 ADITOPRIM 56066-63-8 ACEDAPSONE 77-46-3 ADOSOPINE 88124-26-9 ACEDIASULFONE SODIUM 127-60-6 ADOZELESIN 110314-48-2 ACEDOBEN 556-08-1 ADRAFINIL 63547-13-7 ACEFLURANOL 80595-73-9 ADRENALONE -
B-Lactams: Chemical Structure, Mode of Action and Mechanisms of Resistance
b-Lactams: chemical structure, mode of action and mechanisms of resistance Ru´ben Fernandes, Paula Amador and Cristina Prudeˆncio This synopsis summarizes the key chemical and bacteriological characteristics of b-lactams, penicillins, cephalosporins, carbanpenems, monobactams and others. Particular notice is given to first-generation to fifth-generation cephalosporins. This review also summarizes the main resistance mechanism to antibiotics, focusing particular attention to those conferring resistance to broad-spectrum cephalosporins by means of production of emerging cephalosporinases (extended-spectrum b-lactamases and AmpC b-lactamases), target alteration (penicillin-binding proteins from methicillin-resistant Staphylococcus aureus) and membrane transporters that pump b-lactams out of the bacterial cell. Keywords: b-lactams, chemical structure, mechanisms of resistance, mode of action Historical perspective Alexander Fleming first noticed the antibacterial nature of penicillin in 1928. When working with Antimicrobials must be understood as any kind of agent another bacteriological problem, Fleming observed with inhibitory or killing properties to a microorganism. a contaminated culture of Staphylococcus aureus with Antibiotic is a more restrictive term, which implies the the mold Penicillium notatum. Fleming remarkably saw natural source of the antimicrobial agent. Similarly, under- the potential of this unfortunate event. He dis- lying the term chemotherapeutic is the artificial origin of continued the work that he was dealing with and was an antimicrobial agent by chemical synthesis [1]. Initially, able to describe the compound around the mold antibiotics were considered as small molecular weight and isolates it. He named it penicillin and published organic molecules or metabolites used in response of his findings along with some applications of penicillin some microorganisms against others that inhabit the same [4]. -
Who Expert Committee on Specifications for Pharmaceutical Preparations
WHO Technical Report Series 902 WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS A Thirty-sixth Report aA World Health Organization Geneva i WEC Cover1 1 1/31/02, 6:35 PM The World Health Organization was established in 1948 as a specialized agency of the United Nations serving as the directing and coordinating authority for international health matters and public health. One of WHO’s constitutional functions is to provide objective and reliable information and advice in the field of human health, a responsibility that it fulfils in part through its extensive programme of publications. The Organization seeks through its publications to support national health strat- egies and address the most pressing public health concerns of populations around the world. To respond to the needs of Member States at all levels of development, WHO publishes practical manuals, handbooks and training material for specific categories of health workers; internationally applicable guidelines and standards; reviews and analyses of health policies, programmes and research; and state-of-the-art consensus reports that offer technical advice and recommen- dations for decision-makers. These books are closely tied to the Organization’s priority activities, encompassing disease prevention and control, the development of equitable health systems based on primary health care, and health promotion for individuals and communities. Progress towards better health for all also demands the global dissemination and exchange of information that draws on the knowledge and experience of all WHO’s Member countries and the collaboration of world leaders in public health and the biomedical sciences. To ensure the widest possible availability of authoritative information and guidance on health matters, WHO secures the broad international distribution of its publica- tions and encourages their translation and adaptation. -
Us Anti-Doping Agency
2019U.S. ANTI-DOPING AGENCY WALLET CARDEXAMPLES OF PROHIBITED AND PERMITTED SUBSTANCES AND METHODS Effective Jan. 1 – Dec. 31, 2019 CATEGORIES OF SUBSTANCES PROHIBITED AT ALL TIMES (IN AND OUT-OF-COMPETITION) • Non-Approved Substances: investigational drugs and pharmaceuticals with no approval by a governmental regulatory health authority for human therapeutic use. • Anabolic Agents: androstenediol, androstenedione, bolasterone, boldenone, clenbuterol, danazol, desoxymethyltestosterone (madol), dehydrochlormethyltestosterone (DHCMT), Prasterone (dehydroepiandrosterone, DHEA , Intrarosa) and its prohormones, drostanolone, epitestosterone, methasterone, methyl-1-testosterone, methyltestosterone (Covaryx, EEMT, Est Estrogens-methyltest DS, Methitest), nandrolone, oxandrolone, prostanozol, Selective Androgen Receptor Modulators (enobosarm, (ostarine, MK-2866), andarine, LGD-4033, RAD-140). stanozolol, testosterone and its metabolites or isomers (Androgel), THG, tibolone, trenbolone, zeranol, zilpaterol, and similar substances. • Beta-2 Agonists: All selective and non-selective beta-2 agonists, including all optical isomers, are prohibited. Most inhaled beta-2 agonists are prohibited, including arformoterol (Brovana), fenoterol, higenamine (norcoclaurine, Tinospora crispa), indacaterol (Arcapta), levalbuterol (Xopenex), metaproternol (Alupent), orciprenaline, olodaterol (Striverdi), pirbuterol (Maxair), terbutaline (Brethaire), vilanterol (Breo). The only exceptions are albuterol, formoterol, and salmeterol by a metered-dose inhaler when used